Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
OBJECTIVES:
Primary
- Determine the feasibility of prospective screening for ovarian cancer in high-risk
patients.
- Determine normal ranges and distributions of CA 125 within and between these patients
(with subclassification by menopausal status, estrogen replacement therapy usage, and
prophylactic oophorectomy).
Secondary
- Determine estimates of the specificity and positive predictive value of a risk of
cancer algorithm suitable for designing a definitive trial of screening for ovarian
cancer in these patients.
OUTLINE: This is a multicenter, pilot study.
Patients undergo blood collection and CA 125 levels are measured at baseline and then every
3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by
the CA 125 results.
Patients are followed at 6 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.
Interventional
Primary Purpose: Screening
Edward E. Partridge, MD
Principal Investigator
University of Alabama at Birmingham
United States: Federal Government
CDR0000353332
NCT00080639
June 2003
Name | Location |
---|---|
Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |